ACTIVE INGREDIENTS

ZINC OXIDE 7.0%

OCTINOXATE 7.5%

OCTISALATE 5.0%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

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.

DIRECTIONS

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

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 A 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.

Keep out of reach of children.

INACTIVE INGREDIENTS

AQUA, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETEARETH-20, CETEARYL ALCOHOL, CETYL DIMETHICONE, SODIUM HYALURONATE, SODIUM PCA, GLYCERIN, CAMELLIA OLEIFERA (JAPANESE GREEN TEA) LEAF EXTRACT, ASCORBIC ACID, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, CITRIC ACID, CYCLOTETRASILOXANE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, TETRASODIUM EDTA, DIAZOLIDINYL UREA

Advanced Protection SPF 30 Monograph

ADVANCED PROTECTION SUNSCREEN SPF-30
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70712-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PCA (UNII: 469OTG57A2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRASODIUM EDTA (UNII: MP1J8420LU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
HYDROGENATED PALM OIL (UNII: 257THB963H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CETEARETH-20 (UNII: YRC528SWUY)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GINKGO BILOBA LEAF (UNII: 19FUJ2C58T)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
CITRIC ACID (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70712-103-11	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025
2	NDC:70712-103-12	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/04/2025

Labeler - BOTANICAL SCIENCE, INC. (783654275)