DAY CREAM SPF 30- octocrylene, octinoxate, avobenzone cream

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Octocrylene 8.0%
Octinoxate 7.5%
Avobenzone 3.0%

Purpose

Suncreen

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.

Directions:

Directions:
Apply liberally 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 arly
skin aging. To decrease thisrisk. regular1y use a sunscreen with a broad spectrum SPFof 15 or
higher and other sun protection measures induding: Limit time in the sun, especially from 10 a.m.-
2 p.m. Wear long-sleeve shirts, pants, hats and sunolasses. Children under 6 months: Ask a
doctor.

Other Information:

Protect this product from excessive heat and direct sun.

Warning:

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 ask a doctor if rash occurs.
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison
Control Center right away.

Keep out of Reach of Children

Keep out of Reach of Children

Inactive Ingredients:

Inactive Ingredients: Water (Aqua), Hydrogenated Polyisobutene, Cetearyl Stearate, Myristyl Myristate, Prunus Armeniaca (Apricot) Kernel Oil, Ceteareth-20, PEG-100 Stearate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Glycyrrhiza Glabra (licorice) Root Extract, Panthenol, Tocopheryl Acetate, Bentonite, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Titanium Dioxide (Cl 77891).

Principal Display Panel

Day Cream SPF 30

All Skin Types

Objective: The best under the sun Strategy: Broad Spectrum SPF 30 Sunscreen provides UV protection.
Natural AHAS - Sugarcane, Sugar Maple, Orange and Lemon Extracts work hard to help erase and
prevent wrinkles. Licorice Root Extract helps to even skin tone and texture. Panthenol helps retain
moisture, while Vitamin E nourishes the skin.

90 ml e 3 fl oz

Anthony

INGREDIENTS AND APPEARANCE

DAY CREAM SPF 30 
octocrylene, octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80949-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUGARCANE (UNII: 81H2R5AOH3)
BILBERRY (UNII: 9P2U39H18W)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
ORANGE (UNII: 5EVU04N5QU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
CETEARETH-20 (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
LEMON (UNII: 24RS0A988O)
BENTONITE (UNII: A3N5ZCN45C)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80949-003-01	90 g in 1 TUBE; Type 0: Not a Combination Product	04/29/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/29/2026

Labeler - Anthony Skin LLC (117392467)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	manufacture(80949-003)