BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 20 FACE SUNSCREEN

Main information

  • Trade name:
  • BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 20 FACE SUNSCREEN - SHEER TINT- zinc oxide lotion
  • Composition:
  • ZINC OXIDE 12 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 20 FACE SUNSCREEN - SHEER TINT- zinc oxide lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Sunscreen - Helps prevent sunburn - If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 62206-4902-0
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 20 FACE SUNSCREEN - SHEER

TINT- zinc oxide lotion

W.S. Badger Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Badger

Damascus Rose Broad Spectrum SPF 20 Face Sunscreen - Sheer Tint

Drug Facts

Active Ingredient

Non-Nano Uncoated Zinc Oxide 12.0%

Purpos e

Sunscreen

Us es

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin

cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right

away.

Directions

For full protection, apply liberally to face and neck 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating

Reapply:

At least every 2 hours

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging

To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and

other sun protection measures including:

Limit time in the sun, especially from 10am-2pm

Wear long-sleeved shirts, pants, hats, and sunglasses

For children under 6 months of age: ask a doctor.

Ingredients

Aloe Barbadensis (Aloe) Leaf Juice,

Helianthus Annuus (Sunflower) Seed Oil, Carthamus

®

Tinctorious (Safflower) Oleosomes,

Sucrose Cocoate (from Coconut),

Alcohol Denat. (38B

Lavender), Leuconostoc Ferment Filtrate (from Radish), Microstalline Cellulose (and) Algin, Citric

Acid, Phenethyl Alcohol,

Glycerin (from Soybean),

Lavandula Angustifolia (Lavender) Flower

Oil,

Hippophae Rhamnoides (Seabuckthorn) Fruit Extract,

Rosa Canina (Rosehip) Fruit Extract,

Rosa Damascena (Rose) Flower Oil,

Anthemis Nobilis (Chamomile) Flower Oil,

Calendula

Officinalis (Calendula) Flower Extract, Xanthan Gum, Sodium Phytate, Sodium Gluconate,

Lecithin

(from Soybean), Tocopherol (Sunflower Vitamin E), Iron Oxides (C.I. 77491) (and) Jojoba Esters,

Iron Oxides (C.I. 77492) (and) Jojoba Esters, Iron Oxides (C.I. 77499) (and) Jojoba Esters.

PRINCIPAL DISPLAY PANEL - 47 ml Tube Box

BADGER

Damascus Rose

with Lavender & Chamomile

BROAD SPECTRUM

SPF 20

ANTI-AGING

FACE SUNSCREEN

SHEER TINT

Protect & Restore

UVA

UVB

NON

NANO

NON

COMEDO-

GENIC

HYPO-

ALLERGENIC

100% CERTIFIED NATURAL

CONTAINS ORGANIC

INGREDIENTS

NATURAL PRODUCTS ASSOCIATION

CERTIFIED

NSF

contains organic

ingredients

47 ml/1.6 fl.oz

= Certified Organic

BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 20 FACE SUNSCREEN -

SHEER TINT

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 220 6 -49 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

12 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

CARTHAMUS TINCTO RIUS SEED O LEO SO MES (UNII: 9 S6 0 Q7230 9 )

SUCRO SE CO CO ATE (UNII: 3H18 P0 UK73)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

LEUCO NO STO C/RADISH RO O T FERMENT FILTRATE (UNII: D2QHA0 3458 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

HIPPO PHAE RHAMNO IDES FRUIT (UNII: AVL0 R9 111T)

RO SA CANINA FRUIT (UNII: 3TNW8 D0 8 V3)

RO SA DAMASCENA FLO WER O IL (UNII: 18 9 20 M3T13)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

CHAMAEMELUM NO BILE FLO WER O IL (UNII: UB2758 78 39 )

XANTHAN GUM (UNII: TTV12P4NEE)

PHYTATE SO DIUM (UNII: 8 8 49 6 G1ERL)

SO DIUM GLUCO NATE (UNII: R6 Q379 1S76 )

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

HYDRO GENATED JO JO BA O IL, RANDO MIZED (UNII: Q47ST0 2F58 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 220 6 -49 0 2-0

1 in 1 BOX

1

47 mL in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

W.S. Badger Company, Inc.

OTC MONOGRAPH NOT FINAL part352

0 8 /0 1/20 14

Labeler -

W.S. Badger Company, Inc. (963242326)

Registrant -

Norwood Packaging Ltd. (243693926)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

No rwo o d Packaging Ltd.

2436 9 39 26

MANUFACTURE(6 220 6 -49 0 2)

Revised: 6/2014