SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT- avobenzone, homosalate, octisalate, octocrylene lotion

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT by

Drug Labeling and Warnings

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT by is a Otc medication manufactured, distributed, or labeled by Session Savers Sunscreen LLC, Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT

Active ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 6%

Purpose

Sunscreen

Uses

• helps prevent sunburn.
• if used as directed with other sun protection 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 Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Skin Cancer/Skin Aging Alert: 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 sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
  

Other information

• protect the product in this container from excessive heat and direct sun
• store in a cool, dry place
  

Inactive ingredients

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Ceteth-20, Cetyl Dimethicone, Cetyl Peg/-75 Stearate, Fragrance, Glycerin, Methylisothiazolinone, Polyglyceryl-4 Isostearate, Sorbitan Olivate, Steareth-20, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum

Questions or comments?

CALL TOLL FREE 1-866-954-4SUN (1-866-954-4786)

SESSION SAVERS Sunscreen SPF 30

is distributed by: SESSION SAVERS SUNSCREEN, LLC., San Diego, CA 92169 USA. SESSION SAVERS Sunscreen SPF 30, if used as directed with other sun protection measures (see Directions in the Drug Facts chart), decreases the risk of skin cancer and early skin aging caused by the sun. Do not use near heat or open flame. May stain fabrics.

8  58879 0040  4

PRINCIPAL DISPLAY PANEL

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30

NDC: 58481-000-00

WATER RESISTANT (80 Minutes)

ULTRA CONVENIENT  MADE IN USA

SESSION SAVERS SPF 30 BROAD SPECTRUM SUNSCREEN

10 Pocket Packs

0.004 fl oz (1.3ml) each
net contents 0.44 fl oz (13ml)

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT 10 Pack (

58481-000-00)

INGREDIENTS AND APPEARANCE

SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58481-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETETH-20 (UNII: I835H2IHHX)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARETH-20 (UNII: L0Q8IK9E08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58481-000-00	10 in 1 BLISTER PACK	06/24/2013
1		1.3 mL 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	06/24/2013

Labeler - Session Savers Sunscreen LLC (078785992)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(58481-000)