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

BEAST HYDRATING FACE SPF-20 by

Drug Labeling and Warnings

BEAST HYDRATING FACE SPF-20 by is a Otc medication manufactured, distributed, or labeled by Small Batch Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73095-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
MELISSA OFFICINALIS (UNII: YF70189L0N)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ROSEMARY (UNII: IJ67X351P9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73095-085-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2019

Labeler - Small Batch Beauty, LLC (079861262)