PHARMACA NATURAL MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium Dioxide, 6.0%, Zinc Oxide, 6.0%, Sunscreen
Available from:
Pharmaca Integrative Pharmacy, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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.
Authorization status:
OTC monograph not final
Authorization number:
62082-055-03

PHARMACA NATURAL MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide cream

Pharmaca Integrative Pharmacy, 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.

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PHARMACA Natural Mineral Sunscreen SPF-30

DRUG FACTS

Active Ingredients

Titanium Dioxide, 6.0%

Zinc Oxide, 6.0%

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. Keep product out of eyes. Rinse with water to remove.

Stop use and consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions :

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours, and immediately

after swimming, sweating or towel drying. Sun protection measures: Spending time in the sun

increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen

with broad-spectrum protection and an SPF rating of 15 or higher. Other recommendations: Limit time

in sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician.

Other ingredients:

aloe barbadensis (aloe vera gel) juice, aqua (deionized water), butyrospermum parkii (shea) butter,

camellia sinensis (green tea) extract, cocos nucifera (coconut) oil, dehydroxanthan gum,

gluconolactone, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) oil, lecithin,

mangifera indica, (mango) butter, sodium benzoate, sodium laurylglucosides hydroxypropylsulfonate,

styrene/acrylates copolymer, tocopheryl (vitamin e), xanthan gum

For maximum effectiveness:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

PHARMACA NATURAL MINERAL SUNSCREEN SPF-30

Pharmaca Integrative Pharmacy, Inc.

titanium dioxide, zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 8 2-0 55

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

6 0 mg in 1 mL

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

6 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

WATER (UNII: 0 59 QF0 KO0 R)

SHEA BUTTER (UNII: K49 155WL9 Y)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

DEHYDRO XANTHAN GUM (UNII: 6 3ZP7I1BQO)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO YBEAN O IL (UNII: 241ATL177A)

HELIANTHUS ANNUUS FLO WERING TO P (UNII: BKJ0 J3D1BP)

MANGIFERA INDICA BARK (UNII: S242WH4US3)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

XANTHAN GUM (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 8 2-0 55-0 3

10 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 5/20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/20 /20 19

Labeler -

Pharmaca Integrative Pharmacy, Inc. (031903446)

Revised: 5/2019

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