1177, 1178 SUNSCREEN cream

1177, 1178 Sunscreen by

Drug Labeling and Warnings

1177, 1178 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Dynarex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Purpose

Sunscreen

Uses

. Protects from excessive heat and direct sun

. Helps prevent sunburns

. Higher SPF gives more sunburn protection

. For skin highly sensitive to sunburn

Warnings

For External Use Only.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging.

Do not use

On damaged or broken skin

When using this product

. Keep out of eyes

. Rinse with water to remove

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away.

Directions

. Apply liberally 15 minutes before sun exposure

. Reapply at least every 2 hours

. Children under 6 months: as a doctor

Inactive ingredients

Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine

Questions?

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Label

1177 Sunscreen

Label

1177, 1178 Sunscreen

INGREDIENTS AND APPEARANCE

1177, 1178 SUNSCREEN 
1177, 1178 sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-177
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-177-01	24 in 1 CASE	05/27/2021
1	NDC: 67777-177-11	25 in 1 BOX
1		3.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-177-02	1000 in 1 CASE	05/27/2021
2		3.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/27/2021

Labeler - Dynarex (008124539)