BEAST HYDRATING FACE SPF-20- octocrylene, octisalate, avobenzone lotion

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

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Active ingredient:
Octocrylene 5.00% Octisalate 5.00%, Avobenzone 3.00%, Sunsreen
Available from:
Small Batch Beauty, LLC
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:
73095-085-03

BEAST HYDRATING FACE SPF-20- octocrylene, octisalate, avobenzone lotion

Small Batch Beauty, LLC

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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BEAST HYDRATING FACE LOTION SPF-20

Drug Facts

Active ingredients

Octocrylene 5.00% Octisalate 5.00%

Avobenzone 3.00%

Purpose

Sunsreen

Uses

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.

When using this product

keep 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.

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, along with other sun protection measures including: Limit time in the

sun, especially between 10am and 2pm.

Wear long sleeve shirts, pants, hats and sunglasses.

For children under 6-months, consult a physician.

Other ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobils (Chamomile)

Oil, Aqua (Deionized Water), Buddleja Davidii Meristem Cell Culture, Calendula Officinalis Extract,

Caprylic/Capric Triglyceride, Carum Petroselinum (Parsley) Extract, Cetearyl Olivate, Cetyl Alcohol,

Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil,

Hyaluronic Acid, Leontopodium Alpinum (Edelweiss Stem Cell) Extract, Lavandula Angustifolia

(Lavender) Oil, Lumineria (Algae) Extract, Malus Domestica Fruit Cell Culture Extract, Melissa

Officinalis (Lemon Balm) Extract, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol,

Polysorbate-20, Retinyl palmitate (Vitamin A), Rosmarinus Officinalis Extract, Sorbitan Olivate,

Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Other information

Protect this product from excessive heat and direct sunlight.

Package Labeling:

BEAST HYDRATING FACE SPF-20

octocrylene, octisalate, avobenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 9 5-0 8 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

50 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

50 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID CO PO LYMER ( 18 0 0 0 MW) (UNII:

JZ1374NL9 E)

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

CHAMO MILE (UNII: FGL36 8 5T2X)

WATER (UNII: 0 59 QF0 KO0 R)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PETRO SELINUM CRISPUM (UNII: 1WZA4Y9 2EX)

CETEARYL O LIVATE (UNII: 58 B6 9 Q8 4JO)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

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

HYALURO NIC ACID (UNII: S270 N0 TRQY)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

PHYMATO LITHO N CALCAREUM (UNII: 6 J1M3WA0 ZK)

MELISSA O FFICINALIS (UNII: YF70 18 9 L0 N)

GERANIUM O IL, ALGERIAN TYPE (UNII: 5Q1I9 4P4WG)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

RO SEMARY (UNII: IJ6 7X351P9 )

SO RBITAN O LIVATE (UNII: MDL271E3GR)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

XANTHAN GUM (UNII: TTV12P4NEE)

CO RN (UNII: 0 N8 6 7270 7O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 9 5-0 8 5-0 3

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

0 5/0 1/20 19

Small Batch Beauty, LLC

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 5/0 1/20 19

Labeler -

Small Batch Beauty, LLC (079861262)

Revised: 5/2019

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