Drug Facts

Active ingredients

Avobenzone 2.8%

Octocrylene 5%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert: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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: Ask a doctor

Other Information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

diisostearyl malate, hydrogenated polyisobutene, bis-diglyceryl polyacyladipate-2, isopropyl myristate, microcrystalline wax, shea (Butyrospermum parkii) butter, isoamyl p-methoxycinnamate, silica, polyglyceryl-3 diisostearate, tocopheryl acetate, fragrance (parfum), argan tree (Argania spinosa) kernel oil, coconut (Cocos nucifera) oil, water (aqua), butylene glycol, peach (Prunus persica) leaf extract, benzyl benzoate.

Package Labeling:

UpdatedLabel

CAO COSMETIC LIP SUNSCREEN SPF 30
avobenzone, octocrylene ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82564-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SHEA BUTTER (UNII: K49155WL9Y)
AMILOXATE (UNII: 376KTP06K8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PRUNUS PERSICA LEAF (UNII: VN3501T41P)
BENZYL BENZOATE (UNII: N863NB338G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82564-000-01	1 in 1 CARTON	10/01/2022
1		6 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	10/01/2022

Labeler - S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED (660783924)

Name	Address	ID/FEI	Business Operations
Establishment
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED		660783924	manufacture(82564-000)

CAO Cosmetic Lip Sunscreen SPF 30