SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15- ethylhexyl methoxycinnamate, octocrylene gel

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Guangzhou Tata Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

protect lips from damaging UVA and UVB rays.

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Step 1:Saueeze tube.

Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.

Step3:Reapply after periods of swimming exercise and towel drying or as required.

OTHER SAFETY INFORMATION

Protect this product from excessive heat anddirect sun.
Sun alert: Limiting sun exposure, wearing protective clothing,and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects of the sun.

INACTIVE INGREDIENT

Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,

Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol

QUESTIONS

You can email us at info@redi-usa.com for more help!

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 
ethylhexyl methoxycinnamate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84066-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
COCOA (UNII: D9108TZ9KG)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MACADAMIA OIL (UNII: 515610SU8C)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84066-103-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/02/2024

Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Tata Biotechnology Co., Ltd.		699605102	manufacture(84066-103)