anna lotan PRO  SUN Select Clear Silky Sunscreen Gel SPF30

Anna Lotan Clear Silky Sunscreen Gel Broad Spectrum SPF30 by

Drug Labeling and Warnings

Anna Lotan Clear Silky Sunscreen Gel Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANNA LOTAN CLEAR SILKY SUNSCREEN GEL BROAD SPECTRUM SPF30- homosalate, octisalate, oxybenzone, avobenzone, octocrylene gel 
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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anna lotan PRO SUN Select Clear Silky Sunscreen Gel SPF30

Drug Facts

Active ingredients

Homosalate 10.0%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 3.0%
Octocrylene 2.0%

Purpose:

Sunscreen

Uses

Helps 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 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 water resistant sunscreen if swimming or sweating
children under 6 months: Ask a doctor
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 value of 15 or higher and other sun protection measures including:
    limit time in sun from 10 a.m.- 2 p.m.
    wear long-sleeved shirts, pants, hats and sunglasses

Other information

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

Inactive ingredients

Isohexadecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Fragrance, Tocopheryl Acetate, Bisabolol.

Questions or Comments?

Contact: (781) 281-0954

A clear broad spectrum UVA/UVB protective gel that is rapidly absorbed by the skin.
When applied to the skin it leaves nothing but a smooth velvety touch without any whitish residue.
No greasy after-feel is left on the skin which makes this gel optimal for all skin types (including men who tend to prefer an invisible cream).
Vitamin E serves as an antioxidant in this formula to minimize free radical damage, which is very important during exposure to UV light.

PRODUCT OF ISRAEL

Distributed by: Anna Lotan USA Inc.
16 Wheeling Ave. Woburn, MA 01801

info@annalotanusa.com

www.annalotanusa.com

Packaging

ANNA LOTAN CLEAR SILKY SUNSCREEN GEL BROAD SPECTRUM SPF30 
homosalate, octisalate, oxybenzone, avobenzone, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-307-50	1 in 1 CARTON	05/23/2022	06/30/2023
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/23/2022	06/30/2023

Labeler - Anna Lotan Ltd (600458368)

Revised: 7/2023

Document Id: 9a596144-b7eb-46f7-9101-aeb5809447ab

34390-5

Set id: f385da4a-7026-46eb-b92b-5a38ee407093

Version: 2

Effective Time: 20230710