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

ADVANCED PROTECTION SUNSCREEN SPF-30 by

Drug Labeling and Warnings

ADVANCED PROTECTION SUNSCREEN SPF-30 by is a Otc medication manufactured, distributed, or labeled by BOTANICAL SCIENCE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 7.0%

OCTINOXATE 7.5%

OCTISALATE 5.0%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

WARNINGS

FOR EXTERNAL USE ONLY.

• AVOID CONTACT WITH EYES
• DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR
• STOP USE AND CONSULT A DOCTOR IF IRRITATION OR RASH PERSISTS

DIRECTIONS

APPLY TO AREAS EXPOSED TO THE SUN. REAPPLY FREQUENTLY, ESPECIALLY AFTER PHYSICAL ACTIVITY OR SWIMMING.

sUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREENS MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

INACTIVE INGREDIENTS

AQUA, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, CETYL ALCOHOL, CETEARYL ETHYLHEXYLNOATE, CCYCLOPENTASILOXANE, CETARYL ALCOHOL, CETYL DIMETHICONE, ASCORBIC ACID, TOCOPHERYL ACETATE, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, PEG-100 STEARATE, PANAX GINSENG ROOT EXTRACT, CAMELIA OLEIFERA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SODIUM PCA, SODIUM HYALURONATE, XANTHAN GUM, DEHYDROACETIC ACID, TRIETHOXYCAPRYLYLSILANE, BENZYL ALCOHOL, TETRASODIUM EDTA, CITRIC ACID.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70712-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
GINKGO BILOBA WHOLE (UNII: 660486U6OI)
PEG-100 STEARATE (UNII: YD01N1999R)
PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70712-101-11	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/07/2017

Labeler - BOTANICAL SCIENCE, INC. (968444356)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories Inc.		069926483	manufacture(70712-101)