Tinted Day Cream (UVA/UVB) SPF 34

Tinted Day (UVA/UVB) SPF 34 by

Drug Labeling and Warnings

Tinted Day (UVA/UVB) SPF 34 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TINTED DAY (UVA/UVB) SPF 34- ethylhexyl methoxycinnamate, titanium dioxide, oxybenzone cream 
Anna Lotan Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Tinted Day Cream (UVA/UVB) SPF 34

Drug Facts

Active Ingredients

Ethylhexyl Methoxycinnamate 7.5%
Titanium Dioxide 6.65%
Oxybenzone 2.5%

Purpose:

Sunscreen

Uses

● Helps to prevent sunburn
● If used as directed with other sun protective measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

● Apply liberally 15 minutes before sun exposure.
● Reapply:
     after 40 minutes of swimming or sweating
     immediately after towel drying
     at least every 2 hours
● 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 of 15 or higher and other protection measures including:
Limit time in sun from 10 am - 2 pm.
Wear long-sleeve shirts, pants, hats and sunglasses.
● Children under 6 months: Ask a doctor.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glycerin, Caprylic/Capric Triglyceride, Pentaerythrityl Distearate, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Glyceryl Stearate, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan), Panthenol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Sclerotium Gum, Dimethicone, Phenoxyethanol, Xanthan Gum, Sodium Polyacrylate, Butylene Glycol, Caprylyl Glycol, Tocopherol, Fragrance (Parfum), Chlorphenesin, Beta-Sitosterol, Squalene, Disodium EDTA, Iron Oxides.

Questions or Comments?

Contact: info@annalotan-usa.com

Package Labeling:

TINTED DAY (UVA/UVB) SPF 34 
ethylhexyl methoxycinnamate, titanium dioxide, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	66.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
PROPANEDIOL (UNII: 5965N8W85T)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
CHLORPHENESIN (UNII: I670DAL4SZ)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SQUALENE (UNII: 7QWM220FJH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-009-75	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2016	08/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/19/2016	08/31/2019

Labeler - Anna Lotan Ltd. (600458368)

Revised: 8/2019

Document Id: 9141d594-45be-46bc-e053-2a95a90a2bb4

34390-5

Set id: 5cce5b83-b984-44c6-88b8-3041439841fb

Version: 3

Effective Time: 20190829