Creme Extreme (UVA/UVB) SPF 33

Extreme (UVA/UVB) SPF 33 by

Drug Labeling and Warnings

Extreme (UVA/UVB) SPF 33 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTREME (UVA/UVB) SPF 33- ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, octocrylene 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.

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Creme Extreme (UVA/UVB) SPF 33

Drug Facts

Active Ingredients

Ethylhexyl Methoxycinnamate 7.50%

Butyl Methoxydibenzoylmethane 3.00%

Octocrylene 2.80%

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

Aqua (Water), C12-15 Alkyl Benzoate, Sorbitol, Alcohol, Ethylhexyl Methoxycrylene, Commiphora Myrrha Resin Extract, Cetyl Phosphate, Glyceryl Stearate, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Polygonum Aviculare Extract, Titanium Dioxide, PEG-100 Stearate, Mica, Phenoxyethanol, Lonicera Caprifolium (Honeysuckle) Extract, Aloe Barbadensis Leaf Juice Powder, Sodium Polyacrylate, Leontopodium Alpinum Extract, Squalane, Dunaliella Salina Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Parfum (Fragrance), Tocopherol, Silica, Xanthan Gum, Beta-Sitosterol, Squalene, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA.

Questions or Comments?

Contact: info@annalotan-usa.com

Package Labeling:

EXTREME (UVA/UVB) SPF 33 
ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-008
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
MYRRH (UNII: JC71GJ1F3L)
CETYL PHOSPHATE (UNII: VT07D6X67O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SQUALANE (UNII: GW89575KF9)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SQUALENE (UNII: 7QWM220FJH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-008-75	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: 9141a61f-4dec-0192-e053-2995a90a9a3d

34390-5

Set id: 3e7a8cd1-61cf-4555-bbb9-8d153dbb0c97

Version: 3

Effective Time: 20190829